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The addition of idarucizumab to plasma samples containing dabigatran allows the use of routine coagulation assays for the diagnosis of hemostasis disorders
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作者:

Jacquemin, M.
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h-index: 0
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Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium
Univ Hosp Leuven, Dept Clin Lab Med, Leuven, Belgium Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium

Toelen, J.
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Univ Hosp Leuven, Dept Clin Lab Med, Leuven, Belgium Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium

Schoeters, J.
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Univ Hosp Leuven, Dept Clin Lab Med, Leuven, Belgium Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium

van Horenbeeck, I.
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h-index: 0
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Univ Hosp Leuven, Dept Clin Lab Med, Leuven, Belgium Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium

Vanlinthout, I.
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h-index: 0
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Univ Hosp Leuven, Dept Clin Lab Med, Leuven, Belgium Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium

Debasse, M.
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Univ Hosp Leuven, Dept Clin Lab Med, Leuven, Belgium Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium

Peetermans, M.
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Univ Hosp Leuven, Dept Clin Lab Med, Leuven, Belgium Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium

Vanassche, T.
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Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium
Univ Hosp Leuven, Vasc Med & Hemostasis, Leuven, Belgium Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium

Peerlinck, K.
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Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium
Univ Hosp Leuven, Vasc Med & Hemostasis, Leuven, Belgium Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium

van Ryn, J.
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机构:
Boehringer Ingelheim Pharma GmbH & Co KG, Dept CardioMetab Dis Res, Biberach, Germany Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium

Verhamme, P.
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Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium
Univ Hosp Leuven, Vasc Med & Hemostasis, Leuven, Belgium Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium
机构:
[1] Univ Leuven, Ctr Mol & Vasc Biol, Dept Cardiovasc Sci, B-3000 Leuven, Belgium
[2] Univ Hosp Leuven, Dept Clin Lab Med, Leuven, Belgium
[3] Univ Hosp Leuven, Vasc Med & Hemostasis, Leuven, Belgium
[4] Boehringer Ingelheim Pharma GmbH & Co KG, Dept CardioMetab Dis Res, Biberach, Germany
关键词:
dabigatran;
hemophilia A;
idarucizumab;
lupus anticoagulant;
thrombophilia;
THROMBIN TIME;
DOUBLE-BLIND;
LC-MS/MS;
WARFARIN;
PLACEBO;
TESTS;
D O I:
10.1111/jth.13138
中图分类号:
R5 [内科学];
学科分类号:
1002 ;
100201 ;
摘要:
Background: The anticoagulant effect of dabigatran can be approximated by its prolongation of routine coagulation assays. Consequently, dabigatran also interferes with thrombophilia screening or with diagnosing hemostasis disorders that have developed after the initiation of anticoagulant treatment, such as vitamin K deficiency or acquired hemophilia A. Objectives: This study was carried out to determine whether idarucizumab, a humanized antibody fragment that binds dabigatran, could fully neutralize dabigatran in routine diagnostic coagulation assays conducted in vitro, thereby preventing false-positive or false-negative diagnostic readouts. Methods: Preliminary experiments identified coagulation assays that were sensitive to dabigatran, and identified a concentration of idarucizumab that neutralized the effects of dabigatran. These assays were then carried out with patient and control plasma samples spiked with dabigatran, with or without a molar excess of idarucizumab. Results: Dabigatran altered the prothrombin time, activated partial thromboplastin time and thrombin time, and the measurement of intrinsic and extrinsic factor levels. Screening and confirmation tests used for lupus anticoagulant detection were prolonged by dabigatran, falsely suggesting the presence of lupus anticoagulant. Conversely, the addition of dabigatran falsely corrected an abnormal activated protein C resistance ratio. Addition of idarucizumab completely normalized these measurements, and allowed the correct identification of normal and abnormal samples with these assays. Conclusions: In vitro addition of idarucizumab to plasma samples containing dabigatran fully neutralizes the drug, and facilitates the use of routine coagulation assays to allow the diagnosis of hemostasis disorders that may be concurrently present in patients taking dabigatran.
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页码:2087 / 2092
页数:6
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